Clarius Mobile Health has received US FDA clearance for its Ejection Fraction AI tool, expanding the capabilities of its handheld wireless ultrasound platform for cardiac assessment.

The clearance addresses a common challenge in point-of-care ultrasound: assessing left ventricular systolic function quickly and consistently outside formal echocardiography settings. Traditional visual estimation of ejection fraction can be subjective and operator-dependent, limiting confidence among clinicians with less specialised cardiac ultrasound training.

Integrated into the Clarius Ultrasound App, Ejection Fraction AI automatically calculates and displays left ventricular ejection fraction in real time from standard cardiac views. The tool was developed using thousands of clinician-annotated cardiac ultrasound images to support consistent assessment across patient presentations.